Barriers to Effective Weight Loss in Overweight Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2013-11-30

Brief Summary

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The current study aims to investigate the impact of a comprehensive, team-based, family-centered, lifestyle modification program on body weight, metabolic abnormalities, fitness measures, and self-esteem in overweight adolescents beginning the study at ages 11-18 years. The intensive program will uniquely include a "team" structure and a component designed to address the role of parental modeling in effective lifestyle changes. By comparing the demographic, psychosocial, and metabolic characteristics of adolescents according to the degree of weight loss, the study will also more fully characterize the barriers that prevent successful participation in an intensive lifestyle modification program.

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Detailed Description

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The study will annually enroll 100 - 200 adolescent male and female subjects between 11 and 18 years of age with a BMI \> the 85th percentile and one parent. Adolescents enrolled in the study, will participate in a structured exercise program and meet regularly with a dietitian and behavior specialist for nutrition education and review and update of progress and goals. The study is designed for 2 years of participation with data collection points at baseline, 3 months, 6 months, 1 year and 2 years. Data collected from adolescents include demographic information anthropometric information (height, weight, blood pressure, temperature, pulse, percent body fat); assessments of nutritional knowledge, food choices and dietary intake; assessments of activity and fitness level of behavioral status (depression, self-esteem, self-confidence, satisfaction with life, happiness, perspectives on health, exercise and diet, family environment, quality of life, body awareness, teasing, social efficacy, self-perception, coping mechanisms), assessments of sleep time and quality and physiological and medical data (including blood and urine tests)

Parents will accompany their children to the nutrition and behavior support visits, and attend 12 group educational sessions to learn skills and strategies to help their children adopt healthier eating and exercise behaviors. Data collected from parents will include demographic, anthropometric measures (height, weight, blood pressure, temperature, pulse, percent body fat); and assessments of activity level, dietary intake and eating habits, behavioral status, child-feeding practices, and understanding of their child.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lifestyle Modification

Parents are randomized to attend 12 educational sessions covering strategies to manage children's health behaviors.

Group Type EXPERIMENTAL

Lifestyle modification

Intervention Type BEHAVIORAL

Dietary modification and regular physical activity

Control

Teen participates in lifestyle intervention, but parent does not attend parent education sessions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle modification

Dietary modification and regular physical activity

Intervention Type BEHAVIORAL

Other Intervention Names

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Weight Loss Wellness

Eligibility Criteria

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Inclusion Criteria

* Age between 11 and 18
* BMI at or above the 85th percentile for age and sex
* At least one adult in the household who is committed to come to the program meetings

Exclusion Criteria

* Previous enrollment in VCU IRB 3354
* Underlying genetic, neurologic, endocrine, or metabolic conditions that preclude weight loss with conventional diet and exercise programs
* Weight greater than 400 pounds
* Pregnancy in female adolescent subjects
* Inability to understand program instructions due to language barrier or a mental disability
* Primary residence outside a 30 mile radius program facility.
* Primary participating parent, if female, cannot be pregnant during the period corresponding to the parents intervention.

Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes